Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer

NCT07885540 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: ES-2026-042-03
• Study Type: interventional
• Target: 1,278
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pneumonia (POP) affects 4%-24% of lung cancer surgery patients, increasing mortality, stay, costs and worsening prognosis, especially in older patients. Perioperative immunosuppression and synergistic influenza/pneumococcal infection support perioperative vaccination, which may also induce trained immunity; thoracic surgery data are lacking. This multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial will enroll \~1278 patients aged ≥50 undergoing anatomical lung resection for pulmonary nodules or lung cancer, randomized 1:1 to vaccination or no vaccination, with 180-day follow-up. Randomization uses a computer-generated, site-stratified block sequence, concealed via central IWRS or sealed envelopes. An unblinded team handles screening, randomization and vaccination data; surgeons and assessors are blinded. No site may exceed 50% of enrollment. Vaccination group receives 23-valent pneumococcal polysaccharide and quadrivalent influenza vaccines intramuscularly in separate arms 14-28 days preoperatively. Controls receive no vaccine/placebo, with surgery scheduled 14-28 days after randomization. Concomitant indicated treatments are permitted and recorded. Primary endpoint is POP per modified CDC/NHSN criteria: new/progressive imaging infiltrate (excluding atelectasis, edema, embolism, tumor), plus ≥1 clinical sign (fever \>38 °C, WBC ≤4000 or ≥12,000/mm³, or altered mental status if ≥70 years) and ≥2 respiratory signs. Findings on days 3-5 are excluded unless persistent/worsening. Microbiology is confirmatory, not required.

Conditions

Influenza Vaccines; Preoperative; Lung Resection Surgery; Thoracic Surgery; Pneumococcal Polysaccharide Vaccine

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with postoperative pulmonary infection within 30 days after surgery

  Pulmonary infection defined by modified US CDC/NHSN criteria (new or progressive pulmonary infiltrate on imaging, at least 1 clinical sign and at least 2 respiratory signs), confirmed by an independent Endpoint Adjudication Committee blinded to group assignment.

  From surgery to 30 days after surgery

Secondary Outcomes (15)

• Proportion of participants with postoperative pulmonary infection within 90 days after surgery

  From surgery to 90 days after surgery

• Proportion of participants with postoperative pulmonary infection within 180 days after surgery

  From surgery to 180 days after surgery

• Incidence of severe pneumonia

  Within 30, 90 and 180 days after surgery

• Incidence of respiratory failure

  Within 30, 90 and 180 days after surgery

• Incidence of Streptococcus pneumoniae infection

  Within 30, 90 and 180 days after surgery

Study Arms (2)

Vaccination Group

EXPERIMENTAL

23-valent pneumococcal polysaccharide vaccine (0.5 mL) plus quadrivalent split-virion influenza vaccine (0.5 mL), given intramuscularly in separate upper arms 14 to 28 days before surgery, followed by anatomical lung resection and routine perioperative care.

Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: Quadrivalent split-virion influenza vaccine

No Vaccination Group

NO INTERVENTION

No vaccine and no placebo. Surgery is scheduled 14 to 28 days after randomization (routine preoperative respiratory exercises permitted), followed by anatomical lung resection and routine perioperative care.

Interventions

23-valent pneumococcal polysaccharide vaccine BIOLOGICAL

Single 0.5 mL intramuscular dose in one upper arm, completed 14 to 28 days before surgery, at a community health service center or designated vaccination site.

Vaccination Group

Quadrivalent split-virion influenza vaccine BIOLOGICAL

Single 0.5 mL intramuscular dose in the opposite upper arm from the pneumococcal vaccine, completed 14 to 28 days before surgery, at a community health service center or designated vaccination site.

Vaccination Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 years or older, any sex
• American Society of Anesthesiologists (ASA) physical status I to III
• Pulmonary nodule or lung cancer scheduled, based on imaging evaluation, for anatomical lung resection (including segmentectomy, lobectomy, sleeve resection, etc.)
• Expected postoperative survival of at least 6 months
• Agrees to wait 14 to 28 days after enrollment before surgery
• Signed informed consent and willing to comply with the study protocol

You may not qualify if:

• Previous pneumococcal vaccination within 5 years, influenza vaccination within 1 year, or any other vaccination within 4 weeks
• Known allergy to any vaccine component
• Active autoimmune or inflammatory disease (e.g., Guillain-Barre syndrome, systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, Hashimoto thyroiditis); type 1 diabetes, hypothyroidism controlled by replacement therapy alone, and skin conditions not requiring systemic treatment (e.g., vitiligo, psoriasis) are allowed
• HIV antibody positive; active tuberculosis; active hepatitis B (HBV-DNA above the lower limit of detection); or active hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection)
• Pulmonary infection, or active infection requiring systemic treatment (e.g., severe pneumonia, bacteremia, sepsis), within 1 month before surgery
• Use of antibiotics or antiviral drugs within 1 month before surgery
• History of allogeneic organ transplantation (solid organ or allogeneic bone marrow)
• Other surgery or invasive treatment within 1 month before surgery (diagnostic needle biopsy excluded)
• Emergency surgery, or risk of disease progression (e.g., short tumor doubling time) that does not allow waiting for the 14-day vaccine response window
• Pregnant or breastfeeding women
• Prior neoadjuvant therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.), or planned adjuvant therapy within 30 days after surgery
• Any serious illness, uncontrolled concurrent disease, psychiatric disorder, active or uncontrolled infection, other medical history or laboratory abnormality that, in the investigator's opinion, may interfere with participation or interpretation of results

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

MeSH Terms

Conditions

Influenza, Human

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Yi Zhao

CONTACT

+86 13660689190; snk680@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: PROBE design: participants and the unblinded study team (screening, randomization and vaccination records) know the group assignment. The surgical team and outcome assessors are blinded, and the primary endpoint is adjudicated by an independent Endpoint Adjudication Committee that reviews de-identified materials with all vaccination-related information removed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Guangzhou Respiratory Health Research Institute

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10